FDA.reportPublic FDA data

510(k) K233049

Device
TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck? Chemical Indicator
Applicant
Cs Medical, LLC
510(k) number
K233049
Product code
PSW
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-21
Date received
2023-09-25
Regulation
892.1570
Classification name
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kendall Ashe
Address
2179 E. Lyon Station Rd. Creedmoor NC US 27522 27522

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PSW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230381Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical IndicatorCs Medical, LLC2023-06-07
K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantCs Medical, LLC2020-04-01
K182891TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level DisinfectantsCs Medical, LLC2019-04-12
K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level DisinfectantCs Medical, LLC2016-11-03
K150504GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe ReprocessorPci Medical, Inc.2015-11-16
K051305CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5Cs Medical, LLC2005-08-18